Canada: Patient Safety In E-Health Systems

Previously published in the Electronic Healthcare Law Review, October 2011

Canadians have a right to expect safety in the delivery of healthcare in Canada. Electronic healthcare systems should be no exception.

In Canada, we are fortunate to have a variety of protective mechanisms within which health services are delivered, to regulate and protect all aspects of patient safety. Medical device regulations, where those rules apply, form a small but important part of that regulatory environment.

In addition, there is a strong and increasingly disciplined awareness within the eHealth industry in Canada of the requirement to examine and ensure patient safety across other aspects of these systems, and throughout their deployment lifecycle.

The use of computing and communications technologies to improve patient safety and enhance healthcare delivery to patients is also a reasonable expectation of Canadians, and is a growing reality in this country. The positive impacts of modern logistics and resource management, e-prescription and drug-interaction checking supporting physicians, pharmacists and other caregivers, allergy and similar alert notifications, timely and accurate patient identification and transaction- keeping, readily accessible electronically available diagnostic imaging and laboratory results, and similar care enhancements are increasingly available in many jurisdictions. These and other upcoming major changes in information accessibility and use make big differences in the delivery of care to Canadian patients.

Electronic records and health information systems encompass much more than conventional medical devices, providing correct personal identification, accurate communication of test and treatment results and information, secure and complete interactions supporting diagnosis and treatment with clinicians and medical technologies, easy to use home-care devices, and correct sharing of data in various patient e-records. Soon, systems may provide even greater support to clinicians and caregivers, guiding best practices and supporting diagnostic and treatment decisions.

These large-scale integrated and multipurpose health systems include software and hardware that is inherently more complex and which includes greater technical and semantic interoperability challenges, complex multiple interconnectivity requirements, and many levels of security and protections for privacy and appropriate access and audit, than ever before.

The avoidance of the introduction of new risks to patient safety is a paramount concern at all stages of lifecycle of these new systems and their associated health software, from inception and design through development, code generation, specification, site-specific modification, procurement and acquisition, installation, customization, and eventual use, modification, and improvement (and eventual decommissioning and replacement).

The configuration, integration and clinical use of these information and communications systems to enable patient-centred care across multiple sites, hospitals, clinics, physicians and providers, and other agencies is much more complex and involves many more parties and systems than ever before.

Risks associated with these systems have to be proactively identified and managed by clinicians, care-provider organizations, and health informatics professionals as a matter of course, inherent in their development and use, embedded in their thinking and operations — and in a disciplined and thoughtful manner.

Such risks, starting at the design and development stages, need to be understood and mitigated by the right process, attribute and risk management practices and standards, appropriate to the risk and stage in the lifecycle.

As an example, the ISO13485 standard imposed by Health Canada to regulate the design and sale of medical devices in Canada, is a very useful process standard for reducing risk through consistent application of quality management processes in manufacturing. It is applied by hardware and software manufacturers to the production and design/development of devices which are sold in Canada for the purpose of diagnosis and treatment of patients.

That device-centric standard, however useful, is not sufficient to address risk mitigation throughout the entire lifecycle of these larger scale, highly configured, highly interoperable and multi-purpose/multi-party computer and communications systems.

An ISO Technical Report being prepared with major Canadian contributions is being proposed to the ISO Technical Committee (TC215) on Health Informatics to provide guidance on standards which appropriately address a variety of different risks associated with the design, development, configuration, integration, deployment and use/modification of health software.

The Technical Report will identify a proposed suite of standards describing internationally acceptable best practices, either available today or which will be developed, to manage risks across identifiable stages and steps in the lifecycle of health software, across all levels of software from components to applications to enterprise systems.

Even those standards, once identified, adopted and applied by industry, software integrators, healthcare IT departments, system operators and clinician users, will not be sufficient. The people, processes and management of eHealth in Canada will need to continue to embrace our industry's culture of patient safety in the planning, development, delivery and operation of eHealth systems.

The reinforcement of that "patient safety culture" for eHealth software and systems will require ongoing awareness building, training programs, safety assessments, safety incident monitoring, incident reporting without blame, process improvement, and safety certification for both people and systems as appropriate.

We all have to consider the ecology of regulation within which healthcare delivery systems, including software and eHealth systems, operate and ensure that patient safety is one of the paramount goals of all parts of that ecology.

The regulation of patient safety includes licensing, certification, testing and incident reporting, both with respect to people and devices, along the continuum of patient care. But it also includes a thoughtful and deliberate approach to understanding system lifecycles, types of risks and ability to control risks at different steps in the lifecycle, and then training and reinforcing a cultural focus within the human side of these operations which continues to focus on patient safety, without being unduly distracted by efficiencies or particular technologies.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions